title: Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista).
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults.
  
  
  METHODS
  This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments.
  
  
  RESULTS
  A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit.
  
  
  CONCLUSIONS
  This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.
authors.affiliation: Department of Ophthalmology, Oregon Health and Science University, Eugene, OR, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Packer
authors.forename: Luther
authors.initials: L
authors.lastname: Fry
authors.forename: Kevin T
authors.initials: KT
authors.lastname: Lavery
authors.forename: Robert
authors.initials: R
authors.lastname: Lehmann
authors.forename: James
authors.initials: J
authors.lastname: McDonald
authors.forename: Louis
authors.initials: L
authors.lastname: Nichamin
authors.forename: Brian
authors.initials: B
authors.lastname: Bearie
authors.forename: Jon
authors.initials: J
authors.lastname: Hayashida
authors.forename: Griffith E
authors.initials: GE
authors.lastname: Altmann
authors.forename: Omid
authors.initials: O
authors.lastname: Khodai
keywords: cataract surgery; enVista; glistenings; hydrophobic acrylic; intraocular lens